Trial Outcomes & Findings for A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants (NCT NCT06331156)

Last Updated: 2025-10-22

Results Overview

Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (\>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (\<) 1:8 at pre-vaccination, \>= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer \>= 1:8 at pre-vaccination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

At Month 3.5 (1 month post-Dose 3 of IPV)

Results posted on

2025-10-22

Participant Flow

This study was conducted in China.

A total of 400 participants were included in Enrolled set, out of which only 392 were included in Exposed set and started the study.

Participant milestones

Participant milestones
Measure	Staggered Group Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Overall Study STARTED	199	193
Overall Study COMPLETED	186	189
Overall Study NOT COMPLETED	13	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Staggered Group Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Migrated / Moved from the study area	4	3
Overall Study Other	7	0
Overall Study Adverse event requiring expedited reporting	0	1

Baseline Characteristics

A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Staggered Group n=199 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=193 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.	Total n=392 Participants Total of all reporting groups
Age, Continuous	8.1 Weeks STANDARD_DEVIATION 1.2 • n=5 Participants	8.2 Weeks STANDARD_DEVIATION 1.3 • n=7 Participants	8.1 Weeks STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	92 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	101 Participants n=7 Participants	204 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	199 Participants n=5 Participants	193 Participants n=7 Participants	392 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 3.5 (1 month post-Dose 3 of IPV)

Population: Analysis was performed on the per protocol set (PPS) for IPV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-poliovirus types 1, 2, and 3 at 1 month post-Dose 3, participants must have pre- and post-vaccination immunogenicity data for at least one antigen and adhered to the interval between Dose 3 and blood sample at the specified timepoint.

Outcome measures

Outcome measures
Measure	Staggered Group n=125 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=143 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) anti-poliovirus serotype1	99.2 Percentage of participants Interval 95.6 to 100.0	99.3 Percentage of participants Interval 96.2 to 100.0
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) anti-poliovirus serotype2	100 Percentage of participants Interval 97.1 to 100.0	99.3 Percentage of participants Interval 96.2 to 100.0
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) anti-poliovirus serotype3	100 Percentage of participants Interval 97.1 to 100.0	100 Percentage of participants Interval 97.5 to 100.0

SECONDARY outcome

Timeframe: At Month 3.5 (1 month post-Dose 3 of IPV)

Population: Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis.

Outcome measures

Outcome measures
Measure	Staggered Group n=125 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=143 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab anti-poliovirus serotype2	194.95 Titers Interval 168.13 to 226.06	190.44 Titers Interval 164.9 to 219.94
Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab anti-poliovirus serotype1	1369.71 Titers Interval 1140.65 to 1644.78	1374.44 Titers Interval 1148.21 to 1645.25
Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab anti-poliovirus serotype3	451.36 Titers Interval 389.37 to 523.23	450.15 Titers Interval 395.92 to 511.79

SECONDARY outcome

Timeframe: At Month 3.5 (1 month post-Dose 3 of IPV)

Population: Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis.

Outcome measures

Outcome measures
Measure	Staggered Group n=125 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=143 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 anti-poliovirus serotype1, >=1:8	100 Percentage of participants Interval 97.1 to 100.0	100 Percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 anti-poliovirus serotype1, >=1:64	100 Percentage of participants Interval 97.1 to 100.0	100 Percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 anti-poliovirus serotype2, >=1:8	100 Percentage of participants Interval 97.1 to 100.0	100 Percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 anti-poliovirus serotype2, >=1:64	91.2 Percentage of participants Interval 84.8 to 95.5	91.6 Percentage of participants Interval 85.8 to 95.6
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 anti-poliovirus serotype3, >=1:8	100 Percentage of participants Interval 97.1 to 100.0	100 Percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64 anti-poliovirus serotype3, >=1:64	98.4 Percentage of participants Interval 94.3 to 99.8	99.3 Percentage of participants Interval 96.2 to 100.0

SECONDARY outcome

Timeframe: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)

Population: Analysis was performed on the PPS for RV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-RV IgA analyses at 1 month post Dose 2 of HRV PCV-free, participants should have pre- and post-vaccination immunogenicity results and should have complied with the interval between HRV Dose 2 and the post HRV PCV-free Dose 2 blood sample at the specified timepoint.

Seroconversion for anti-RV IgA Ab is defined as: anti-RV IgA Ab concentration \>= 20 unit per milliliter (U/mL) at 1 month post-Dose 2 of HRV PCV-free vaccine, in participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration \< 20 U/mL prior to the first dose of HRV PCV-free vaccine).

Outcome measures

Outcome measures
Measure	Staggered Group n=130 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=146 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab	78.5 Percentage of participants Interval 70.4 to 85.2	90.4 Percentage of participants Interval 84.4 to 94.7

SECONDARY outcome

Timeframe: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)

Population: Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis.

Outcome measures

Outcome measures
Measure	Staggered Group n=130 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=146 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab	160.59 U/mL Interval 114.49 to 225.25	222.15 U/mL Interval 165.98 to 297.34

SECONDARY outcome

Timeframe: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)

Population: Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis.

Outcome measures

Outcome measures
Measure	Staggered Group n=130 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=146 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL	63.8 Percentage of participants Interval 55.0 to 72.1	68.5 Percentage of participants Interval 60.3 to 75.9

SECONDARY outcome

Timeframe: Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group)

Population: Analysis was performed on the Exposed set, which includes all participants who received at least one dose of any of the 2 study interventions and for whom solicited systemic events data were available after the corresponding vaccination for the specified timepoint.

Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. Fever is defined as body temperature \>= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	Staggered Group n=197 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=193 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Number of Participants Reporting Any Solicited Systemic Events Vomiting, post vaccination at Month 1	6 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Vomiting, post vaccination at Month 1.5	1 Participants	7 Participants
Number of Participants Reporting Any Solicited Systemic Events Cough/Runny Nose, post vaccination at Day 1	21 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Cough/Runny Nose, post vaccination at Month 0.5	28 Participants	27 Participants
Number of Participants Reporting Any Solicited Systemic Events Cough/Runny Nose, post vaccination at Month 1	27 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Cough/Runny Nose, post vaccination at Month 1.5	23 Participants	22 Participants
Number of Participants Reporting Any Solicited Systemic Events Diarrhoea, post vaccination at Day 1	8 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Diarrhoea, post vaccination at Month 0.5	10 Participants	9 Participants
Number of Participants Reporting Any Solicited Systemic Events Diarrhoea, post vaccination at Month 1	11 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Diarrhoea, post vaccination at Month 1.5	7 Participants	12 Participants
Number of Participants Reporting Any Solicited Systemic Events Fever, post vaccination at Day 1	15 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Fever, post vaccination at Month 0.5	46 Participants	23 Participants
Number of Participants Reporting Any Solicited Systemic Events Fever, post vaccination at Month 1	33 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Fever, post vaccination at Month 1.5	25 Participants	21 Participants
Number of Participants Reporting Any Solicited Systemic Events Irritability/Fussiness, post vaccination at Day 1	15 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Irritability/Fussiness, post vaccination at Month 0.5	11 Participants	19 Participants
Number of Participants Reporting Any Solicited Systemic Events Irritability/Fussiness, post vaccination at Month 1	6 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Irritability/Fussiness, post vaccination at Month 1.5	6 Participants	7 Participants
Number of Participants Reporting Any Solicited Systemic Events Loss of appetite, post vaccination at Day 1	14 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Loss of appetite, post vaccination at Month 0.5	10 Participants	20 Participants
Number of Participants Reporting Any Solicited Systemic Events Loss of appetite, post vaccination at Month 1	5 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Loss of appetite, post vaccination at Month 1.5	5 Participants	4 Participants
Number of Participants Reporting Any Solicited Systemic Events Vomiting, post vaccination at Day 1	12 Participants	—
Number of Participants Reporting Any Solicited Systemic Events Vomiting, post vaccination at Month 0.5	6 Participants	18 Participants

SECONDARY outcome

Timeframe: Within 31 days after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group)

Population: Analysis was performed on the Exposed set, which includes all participants who received at least one dose of any of the 2 study interventions and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint.

Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	Staggered Group n=199 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=193 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) HRV PCV-free: post-Dose 1	38 Participants	45 Participants
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) HRV PCV-free: post-Dose 2	39 Participants	34 Participants

SECONDARY outcome

Timeframe: From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5)

Population: Analysis was performed on the Exposed set, which includes all participants who received at least one dose of any of the 2 study interventions and for whom SAE data were available after the corresponding vaccinations for the specified duration.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.

Outcome measures

Outcome measures
Measure	Staggered Group n=199 Participants Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.	Co-administration Group n=193 Participants Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Number of Participants Reporting Any Serious Adverse Events (SAEs)	30 Participants	30 Participants

Adverse Events

Staggered Group

Serious events: 30 serious events

Other events: 141 other events

Deaths: 0 deaths

Co-administration Group

Serious events: 30 serious events

Other events: 129 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER